Cowen Analysts Happy About Relypsa-Veltassa Launch, Say These Four Things Are Coming

• The share price of Relypsa Inc RLYP has declined 32.09 percent over the past one month, following a 42.17 percent appreciation over the past three months.
• Cowen’s Eric Schmidt has maintained an Outperform rating on the company.
• Data from the drug-drug interaction study for Veltassa suggest a significantly “cleaner” profile for the drug than the in-vitro studies, and Schmidt believes that a favorable label change was possible.

According to the Cowen report, “Relypsa released data from Veltassa's healthy volunteer drug-drug interaction (DDI) study meant to investigate Veltassa's effect on the PK profile of 12 commonly used drugs in CKD and HF patients.”

The Study

The DDI study was initiated following the FDA having approved the drug in October 2015 with a boxed warning regarding potential drug-drug interactions, while recommending a dosing interval of at least six hours relative to other oral medication.

The DDI study tested the PK of 12 out of the 14 drugs listed by the FDA, either concomitantly with Veltassa or with a three-hour dosing interval. While nine of the 12 drugs did not show any clinically significant decline in absorption on concomitant administration, Veltassa did not demonstrate any effect on either the Cmax or AUC of all 12 drugs when administered with a three-hour interval.

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Relypsa now intends to meet with the FDA to “discuss the implications of the human data and any potential impact for Veltassa label.”

Analyst Eric Schmidt expects four potential outcomes of the FDA discussions, including no label change, addition of drug-specific fata to the label, the FDA agreeing to narrow the dosing window to three hours or the boxed warning being removed.

Schmidt, however, mentioned, “Regardless, we take more comfort in the fact that a boxed warning is having limited commercial impact, and that Veltassa's early launch is proceeding smoothly.”